- Catalent Pharma Solutions (Princeton, NJ)
- **Associate Director , Regulatory Affairs ** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... and Catalent employee. The primary duty of the **Associate Director , Regulatory Affairs ** is to...the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to… more
- Merck (North Wales, PA)
- **Job Description** The Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their ... Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. +… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly ... focus on Clinical Regulatory filings and provide regulatory leadership on...you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with- us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...complex scientific and expert regulatory advice and risk assessment for the development of… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with specific ... responsibility for the United States and the Americas and supporting...Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs ( US RA AdPromo)...to the promotion of prescription drugs in the Uniteed States + The individual will require strong verbal and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... objectives. This group also represents Gilead's commercial activities to US regulatory agencies. You will manage the...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 7 or More Years relevant pharmaceutical experience including experience within Regulatory Affairs + Understanding of scientific content and complexities and ... diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Canon USA & Affiliates (Trenton, NJ)
- …req1193** **OVERVIEW** Responsible for pre-market and post-market activities as assigned by the Director , Regulatory Affairs to include new product planning ... regarding regulatory issues as assigned by the Director , Regulatory Affairs . + Provide...work in PST (PST candidates preferred) \#LI-RS1 \#LI-Remote **_About us !_** _Canon Medical Systems USA, Inc., a world leader… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (RA) team members, cross-functional team members, FDA ... therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory ...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience + Managerial experience preferred… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years of relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA submission experience + ... and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + ... US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI,… more
- J&J Family of Companies (Titusville, NJ)
- …of 2) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of 2) located in ... Director , Global Regulatory Leader (GRL) (1...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on the… more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory ...arrangement can also be considered._** Sanofi Inc. and its US affiliates are Equal Opportunity and Affirmative Action employers… more
- Novo Nordisk (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …with life-threatening diseases. We have an exciting opportunity within US Medical Affairs for an Associate Director in our Patient Access and Quality of ... PAQ Virology. The Associate Director of Medical Affairs - PAQ Virology will support the US...conditions of the applicable plans. **For jobs in the United States :** As an equal opportunity employer,… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical Affairs (CDMA) (Open) Location US Specialty Brand Headquarters - USA501 ... Additional Locations Bridgewater, NJ Job Description The Senior Director , Clinical Development Medical Affairs (CDMA) drives...aspects of registration activities with a working knowledge of regulatory affairs , in the development of the… more